Adamis resubmits NDA to FDA for epinephrine pen
Adamis Pharmaceuticals (NASDAQ:ADMP) has resubmitted its NDA to the FDA for its Epinephrine Pre-filled Syringe (PFS) product candidate for the emergency treatment of anaphylaxis.
The resubmission is intended to address issues raised by the FDA in the agency’s June 2016 Complete Response Letter.
“With all of the recent news regarding products in the anaphylaxis market, we believe our product, now so, more than ever, can be a part of the potential solution for patients and payers as there is an obvious need for a low-cost therapeutic alternative like our PFS,” president and CEO, Dr. Dennis Carlo, said in a statement.
“I was encouraged by the results of the Human Factors study in that it showed our product to be intuitive in its use,” he added. “In addition, based on what we have seen, we believe that many individuals would prefer our product over the EpiPen.”
The Human Factors study consisted of testing in trained and untrained adolescents, 12-to-18 years of age, trained and untrained adults, and trained and untrained caretakers.